Foamix medium to severe acne minocycline foam preparation FMX1013 clinical study gets positive top-line results

acne is a chronic inflammatory skin disease that often occurs in the skin lipid glands and hair follicles, and the symptoms are divided into inflammatory (papules and abscesses) and non-inflammatory (open and closed acne), which can seriously affect the face and other areas of the skinrecently, Israel Biotechcompanyannounced that its Minocycline foam formulation FMX101 for moderate to severe acne, FMX101, received positive top-line results in phase 3 clinical studies (FX2017-22)results show edging theof thetrialThe security of the FMX101 is consistent with the data of the previous two Phase 3 trials (FX2014-04 and FX2014-05)Foamix will continue to publish additional data for the three trials in 2018FMX101
FMX101 is a 4% concentration of minocyclin foam developed by Foamix to treat moderate to severe acneTraditional acne treatments mainly use antibiotics, while Solodyn has been the backbone of the treatment for mild, moderate and severe acne, but so far only oraldrug()If THE FMX101 isFDA (approved), it will be the first local mitochonrotherapy, giving patients more choicerelated studies
This published phase 3 clinical study FX2017-22 is a randomized double-blind, vector-controlled clinical phase 3 trial, including 1507 patients with moderate to severe acne in 89 institutions across the United States The patients were randomly divided into two groups, one receiving fmX101 minocycline (4%) foam once a day, and the other receiving a carrier foam preparation once a day for 12 weeks two main therapeutic endpoints were: absolute changes in the inflammatory lesions index at the baseline in week 12, and the percentage of patients who achieved an overall assessment score (IGA) of 0/1 and at least 2 points of improvement The trial also assessed the safety and resistance of FMX101 results showed that in week 12, the preparation group had a decrease of -16.93 in the baseline of inflammatory lesions, while the control group had a decrease of -13.40 (p0.0001, ANCOVA, ITT, MI) In week 12, the proportion of patients who achieved a significant improvement in IGA in the preparation group was 30.80%, compared with 19.63% in the control group (p0.0001, CMH test - stra byecontains center, ITT, MI) in addition, the safety and resistance results of FMX101 have been shown to be good